Endothelial DysfunctionPhase 4NCT05252923
Endothelial Protection in Convalescent COVID-19 Patients
A Phase 4 study testing Sulodexide in people with Endothelial Dysfunction and Inflammation, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
This pilot open-label randomized controlled trial aims to assess if treatment with sulodexide may improve the endothelial status and inflammatory response in post-COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction, Inflammation, Thrombosis
- What is being tested?
- Sulodexide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- male or female
- documented PCR SARS-CoV-2 positive test
- COVID-19 convalescence (define as at least 10 days after the onset of symptoms, no fever for at least 24 hours without the use of antipyretics and improvement of respiratory symptoms)
- informed consent signed
- clinical severity presentation of
Show all 11Show fewer
- Severe the disease is classified as severe if one of the following conditions is met:
- Respiratory distress, respiratory rate ≥30/min Oxygen saturation on room air at rest ≤93%. Partial pressure of oxygen in arterial blood/FiO2 ≤300 mm Hg. Or
- Critical if one of the following conditions is met. Respiratory failure and mechanical ventilation are required. Shock occurs Another organ dysfunction is present
- risk of health complication >50% according to the health risk calculator
- less than 14 days of hospital discharge.
Who cannot join
- concomitant use of another anticoagulant
- known pregnancy
- known hypersensitivity to sulodexide
- need for hospital care at screening
- renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- blood platelet count < 30 000/µL
- other conditions that are judged to carry an increased risk of bleeding as judged by the Investigator
- more than 30 days of clinical onset
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Protection in Convalescent COVID-19 Patients. The Effect of Sulodexide on Serum Levels of Biomarkers for Endothelial Dysfunction. A Pilot Prospective, Randomized, Open-label, Investigator-initiated Trial.
This pilot open-label randomized controlled trial aims to assess if treatment with sulodexide may improve the endothelial status and inflammatory response in post-COVID-19 patients. Survived inpatients with severe-to-critical COVID-19 within 14 days after discharge are randomized to receive sulodexide 250 LSU 1 oral capsule twice daily or no treatment for 8 weeks. Biomarkers of endothelial dysfunction, inflammation, and prothrombotic changes are assessed at 0, 4, and 8 weeks. The hypothesis is that affected endothelial function, pro-inflammatory, and pro-thrombotic changes could be improved with sulodexide treatment in convalescent COVID-19 patients who suffered a severe-to-critical clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.
- Conditions
- Endothelial Dysfunction, Inflammation, Thrombosis, COVID-19
- Being tested
- Sulodexide
- Medical subject headings
- Inflammation, Thrombosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulodexideDrug
Sulodexide 250 LSU 1 oral capsule twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sulodexide | Experimental | Standard treatment plus oral sulodexide Receives: Drug: Sulodexide |
| Control | No intervention | Standard treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of soluble Thrombomodulin
The level of serum soluble Thrombomodulin will be measured at 0, 4, and 8 weeks by ELISA test to detect endothelial dysfunction and its improvement.
Measured: 8 weeks
Secondary outcomes (7)
Serum level of Von Willebrand factor
The level of serum Von Willebrand factor will be measured at 0, and 8 weeks by ELISA test to detect pro-thrombotic status, endothelial dysfunction, and their improvement.
Measured: 8 weeks
Serum level of ICAM-1
The level of serum ICAM-1 will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement.
Measured: 8 weeks
Serum level of VCAM-1
The level of serum VCAM-1 will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement.
Measured: 8 weeks
Serum level of soluble P-selectin
The level of serum soluble P-selectin will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, pro-thrombotic changes, endothelial dysfunction, and their improvement.
Measured: 8 weeks
Serum level of circulating endothelial cells
The level of circulating endothelial cells will be measured at 0, and 8 weeks by standardized flow cytometry to detect endothelial dysfunction and its improvement
Measured: 8 weeks
Serum level of high sensitive C reactive protein
The level of high sensitive C reactive protein will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement.
Measured: 8 weeks
Serum level of Interleukine-6
The level of serum Interleukine-6 will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Apr 2022
- Primary completion1 Sep 2022
- Study completion31 Dec 2022
Why it stopped: Lack of the eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirill Lobastov, PhD, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252923
- Sponsor's protocol ID
- SDXbioCOVID-19
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Protection in Convalescent COVID-19 Patients. The Effect of Sulodexide on Serum Levels of Biomarkers for Endothelial Dysfunction. A Pilot Prospective, Randomized, Open-label, Investigator-initiated Trial.
- ClinicalTrials.gov ID
- NCT05252923
- Acronym / sponsor ID
- SDXbioCOVID-19
- Conditions
- Endothelial Dysfunction, Inflammation, Thrombosis, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of the eligible patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot open-label randomized controlled trial aims to assess if treatment with sulodexide may improve the endothelial status and inflammatory response in post-COVID-19 patients. Survived inpatients with severe-to-critical COVID-19 within 14 days after discharge are randomized to receive sulodexide 250 LSU 1 oral capsule twice daily or no treatment for 8 weeks. Biomarkers of endothelial dysfunction, inflammation, and prothrombotic changes are assessed at 0, 4, and 8 weeks. The hypothesis is that affected endothelial function, pro-inflammatory, and pro-thrombotic changes could be improved with sulodexide treatment in convalescent COVID-19 patients who suffered a severe-to-critical clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulodexide | Experimental | Drug: SulodexideStandard treatment plus oral sulodexide |
| Control | No intervention | –Standard treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- over 18 years old
- male or female
- documented PCR SARS-CoV-2 positive test
- COVID-19 convalescence (define as at least 10 days after the onset of symptoms, no fever for at least 24 hours without the use of antipyretics and improvement of respiratory symptoms)
- informed consent signed
Key exclusion criteria (8 listed)
- concomitant use of another anticoagulant
- known pregnancy
- known hypersensitivity to sulodexide
- need for hospital care at screening
- renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulodexideSulodexide 250 LSU 1 oral capsule twice daily for 8 weeks | Drug | Sulodexide |
Primary outcome
Serum level of soluble Thrombomodulin
Time frame: 8 weeks
The level of serum soluble Thrombomodulin will be measured at 0, 4, and 8 weeks by ELISA test to detect endothelial dysfunction and its improvement.
7 secondary outcomes
Serum level of Von Willebrand factor
Time frame: 8 weeks
Serum level of ICAM-1
Time frame: 8 weeks
Serum level of VCAM-1
Time frame: 8 weeks
Serum level of soluble P-selectin
Time frame: 8 weeks
Serum level of circulating endothelial cells
Time frame: 8 weeks
Serum level of high sensitive C reactive protein
Time frame: 8 weeks
Serum level of Interleukine-6
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Lack of the eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirill Lobastov, PhD principal investigator
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulodexide in people with Endothelial Dysfunction and Inflammation, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of the eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of soluble Thrombomodulin (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.